BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALLSTENT-UNI¿ ENDOPROSTHESIS

    MDR report key: 2191880 · Received August 4, 2011

    Report

    Report Number
    2134265-2011-03365
    Event Type
    Malfunction
    Date Received
    August 4, 2011
    Date of Event
    July 4, 2011
    Report Date
    July 7, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    JCT
    PMA / PMN Number
    K992510
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER, EVALUATION SUMMARY ATTACHED, METHOD, RESULT CODES, CONCLUSION: UPDATED. THE COMPLAINT DEVICE WAS RETURNED FOR ANALYSIS. AN EXAMINATION OF THE DEVICE FOUND THAT THE STENT WAS FULLY MOUNTED. IT WAS POSSIBLE TO DEPLOY THE STENT WITHOUT ANY ISSUE NOTED. EXAMINATION OF THE DEPLOYED STENT FOUND NO ANOMALIES. A VISUAL AND TACTILE EXAMINATION FOUND NO ISSUES WITH THE SHAFT OR PROFILE OF THE STENT DELIVERY SYSTEM. THE RADIO-OPAQUE (RO) MARKERBANDS WERE MEASURED AND IT WAS CONFIRMED THAT THEY WERE POSITIONED CORRECTLY FOR THIS DEVICE INDICATING THAT THE STENT WAS THE CORRECT SIZE. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. DEVICE ANALYSIS DETERMINED THAT NO ISSUES WERE NOTED WITH THE RETURNED DEVICE WHICH COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MFR#: 2134265-2011-03364. IT WAS REPORTED THAT DURING PREPARATION FOR A STENTING TREATMENT PROCEDURE, AN INCORRECT STENT LENGTH WAS NOTED. IT WAS NOTED BY THE PHYSICIAN UPON OPENING THE PACKAGE FOR AN 8 X 80MM X 100CM WALLSTENT THAT THE WRONG LENGTH STENT WAS IN THE PACKAGE. THE PHYSICIAN OPENED ANOTHER PACKAGE FOR AN 8 X 80MM X 100CM WALLSTENT AND NOTED THE SAME THING. THERE WAS NO PATIENT INVOLVED.

    Description of Event or Problem · 1

    SAME CASE AS MFR#: 2134265-2011-03364. IT WAS REPORTED THAT DURING PREPARATION FOR A STENTING TREATMENT PROCEDURE, AN INCORRECT STENT LENGTH WAS NOTED. IT WAS NOTED BY THE PHYSICIAN UPON OPENING THE PACKAGE FOR AN 8 X 80MM X 100CM WALLSTENT THAT THE WRONG LENGTH STENT WAS IN THE PACKAGE. THE PHYSICIAN OPENED ANOTHER PACKAGE FOR AN 8 X 80MM X 100CM WALLSTENT AND NOTED THE SAME THING. THERE WAS NO PATIENT INVOLVED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WALLSTENT-UNI¿ ENDOPROSTHESIS PROSTHESIS, TRACHEAL, EXPANDABLE JCT BOSTON SCIENTIFIC - GALWAY M001731300 13490707

    Patients

    Seq Age Sex Outcome Treatment
    1